Infusion of 5-Azacytidine (5-AZA) Into the Fourth Ventricle in Children With Recurrent Posterior … (NCT02940483) | Clinical Trial Compass
CompletedEarly Phase 1
Infusion of 5-Azacytidine (5-AZA) Into the Fourth Ventricle in Children With Recurrent Posterior Fossa Ependymoma
United States6 participantsStarted 2017-02-01
Plain-language summary
The goal of this clinical research study is to establish the safety of direct administration of 5-Azacytidine into the fourth ventricle of the brain or resection cavity in patients with recurrent posterior fossa ependymoma.
Who can participate
Age range1 Year – 21 Years
SexALL
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Inclusion Criteria:
* Diagnosis: Patients with histologically verified ependymoma, with recurrence or progression involving anywhere in the brain and/or spine. To be eligible, patients' disease must have originated in the posterior fossa of the brain.
* Patient must have either measurable or evaluable tumor as assessed by MRI of the brain and total spine.
* An implanted catheter in the fourth ventricle or posterior fossa tumor cavity attached to a ventricular access device or agreement to have one placed.
* A minimum of 7 days between last dose of systemic chemotherapy and/or radiation therapy and first infusion of 5-Azacytidine into fourth ventricle.
* Life expectancy of at least 12 weeks in the opinion of the PI
* Lansky score of 50 or greater if ≤16 years of age or Karnofsky score of 50 or greater if \> 16 years of age.
* Existing neurological deficits must have been stable for a minimum of 1 week prior to study enrollment.
* Patients must have recovered from the acute toxic effects of all prior anticancer chemotherapy
* Adequate bone marrow function defined by peripheral absolute neutrophil count (ANC) ≥ 500/µL, platelet count ≥ 50,000/ µL (transfusion independent), and hemoglobin ≥9.0 gm/dL (may receive RBC transfusions)
* Patient or patient's legal representative, parent(s), or guardian able to provide written informed consent.
Exclusion Criteria:
* Enrolled in another treatment protocol
* Has received another investigational or chemotherapy agent or radiation therap…
What they're measuring
1
Number of patients with grade 3 through grade 5 new neurological adverse events that are related to study drug, graded according to NCI CTCAE Version 4.0
Timeframe: 4 months
Trial details
NCT IDNCT02940483
SponsorThe University of Texas Health Science Center, Houston